Senior Clinical Project Assistant

The Senior Clinical Project Assistant role is suitable for an experienced professional with an advanced level of knowledge and familiarity as a Clinical Project Assistant. This position requires organizational skills with a high attention for detail and must have the ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple projects. Excellent verbal and written communication skills are essential. This position will support the Clinical Project Managers, Clinical Research Associates and Study Team for the management of ongoing clinical studies. The Senior Clinical Project Assistant is an integral member of the clinical project team providing support and troubleshooting on various aspects of project and will act as a leading role for fellow Project Assistants.

Responsibilities

  • Provide clinical project management support for Project Managers, CRAs, and Sponsors to ensure site compliance and study team performance within project timelines.
  • Accurately update and maintain study relevant documents such as trackers, meeting minutes/agendas and study data to monitor project status.
  • Act as a central contact for the clinical sites for designated project communications, correspondence and associated documentation
  • Apply knowledge of company policies and regulatory standard practices to resolve problems
  • Support Project Managers, CRAs and Sponsors with development, preparation, handling and distribution of Study Supplies (i.e. relevant study binders and packets) and manage distribution status per study.
  • Set Up study files and maintain records in the Clinical Trial Management Systems (paper TMF, eTMF, etc.)
  • Act as a liaison by actively engaging in-depth communications with partners and vendors regarding study related events and supplies management.
  • Support sponsors and Project Manager with distributing, requesting, collecting, and reviewing site regulatory documents for the applicable phase of the clinical study (Study Start Up, Enrollment, Follow-Up, Maintenance, etc.). including a precise quality check (QC) when documents are received.
  • Communicate and provide updates to study team as necessary on all aspects of the study (including but not limited to, collection of regulatory documents, institutional review board (IRB)/EC submissions, follow up visit reminders, study close outs, etc.)
  • Coordinate study materials and assemble, review, and maintain study specific templates and trackers.
  • Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites.
  • May serve as the Lead Clinical Project Assistant on projects.
  • Support sites to ensure compliance to study protocol, timelines and regulatory guidelines
  • Responsible for creating and completing informed consent form (ICF) checklists for applicable sites and studies
  • Responsible for maintaining and tracking all study personnel’s up-to-date training status and information
  • Collect and review safety source documents provided by sites.
  • Serve as a back-up to the Project Managers as needed
  • Serve as back-up to local Manager, Clinical Project Assistant as needed
  • Train and mentor Clinical Project Assistants levels I and II on their primary responsibilities
  • Other project support duties as assigned

Qualifications

  • A bachelor’s degree from a four-year college/university in Business Administration, Life Sciences or another related field.
  • A minimum of two years’ experience in the clinical research industry.
  • Knowledge and experience in the regulatory aspects of clinical research development, including protocol implementation, data collection and reporting, and other regulatory requirements to execute a clinical study.
  • Demonstrate an understanding of medical terminology and industry acronyms
  • Previous experience in reviewing and managing supporting documents for a clinical study
  • Ensures adherence to standard operating procedures, good clinical practice, and regulatory requirements with strong understanding of inspection readiness
  • Proficient in Microsoft Office/Windows. Specifically: MS Word, MS Excel, MS PowerPoint and MS Outlook
  • Excellent written and verbal communication skills including good command of English language
  • Ability to work in a global environment
  • Ability to work independently with exceptional time management and organization skills
  • Provide high attention to detail and level of accuracy
  • Self-starter, committed to finishing projects completely while meeting project deadlines
  • Ability to handle multiple responsibilities and work well under pressure
  • High degree of tact, judgment and discretion
  • Fluent in Good Clinical Practice (GCP), and other applicable regulations/guidelines for clinical research such as ICH and ISO 9001 and is able insure implementation within any clinical study.
  • Must be prepared to travel at times (domestic and internationally) as needed.
  • Multilingual skills are a plus (especially in Spanish, German, Japanese, Italian or Chinese)
City
Lower Gwynedd
State
PA
Job Type
Full-Time Regular
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